Dyadic International Q4 2024 Earnings Call Transcript

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Provided by Quartr
March 26, 2025

There are 7 speakers on the call.

Operator

Good evening, and welcome to Dyadic International's Year End twenty twenty four Conference Call. Currently, all participants are in a listen only mode. Following management's prepared remarks, there will be a brief question and answer session. As a reminder, this conference call is being recorded as of today, 03/26/2025. I would now like to turn the call over to Ms.

Operator

Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead.

Speaker 1

Thank you. Good evening and welcome everyone to Dyadic International's full year twenty twenty four conference call. I hope you have had the chance to review Dyadic's press releases announcing financial results for the fiscal year ended 12/31/2024. You may access our press release and Form 10 K under the Investors session of the company's website at dyadic.com. On today's call, our President and CEO, Mark Imafar and our Chief Operating Officer, Joe Hazleton, will give a review of our 2024 business and corporate highlights and provide a commentary on the strategic direction of the business.

Speaker 1

I will follow with a review of our financial results in more detail. We'll then hold a brief question and answer session. At this time, I would like to inform you that certain commentary made in this conference call may be considered forward looking statements, which involve risks and uncertainties and other factors that could cause Dyadic's actual results, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these forward looking statements. Baddock expressly disclaims any duty to provide updates to its forward looking statements, whether because of new information, future events or otherwise. Participants are directed to the risk factors set forth in Dyadic's reports filed with the SEC.

Speaker 1

It is now my pleasure to pass the call to our CEO, Mark Yinfaq. Mark?

Speaker 2

Thank you, Ping. Welcome, everyone, and thank you for joining Dyadic's full year twenty twenty four conference call. We're excited to share how our strategic focus on near term product, commercialization and technology licensing has positioned Dyadic to capitalize on the current and emerging opportunities. In 2024, we delivered strong revenue performance including $1,900,000 in milestone and license payments, driven by our emphasis on products that do not require human or animal clinical trials for commercialization. These results reflect our commitment to unlocking the full potential of our proprietary C1 and DAPAVIS microbial protein production platforms.

Speaker 2

These platforms are enabling us to generate immediate revenue through high value alternative protein applications, including recombinant human albumin, transferrin, DNase one and alpha lactalbumin. At the same time, we're advancing mid and long term opportunities in human and animal health by applying our platforms to develop antigens, antibodies, enzymes and other proteins that address critical needs in life sciences, food and nutrition and bio industrial markets. Our dual track strategy commercializing near term non pharmaceutical products, while building a robust biopharmaceutical pipeline continues to drive value. We are strengthening our global impact through partnerships with academia, industry government and leading nonprofit and public health organizations. We're proud to be working with the Coalition for Epidemic Preparedness Initiative, CEPI, Foundation Biotechnipolo di Siena and the Gates Foundation and a growing number of other collaborators to accelerate the development and adoption of our C1 platform for vaccines and treatments, supporting global health preparedness and access to affordable biologics.

Speaker 2

As we move forward, TIAAC remains deeply committed to delivering sustainable value to our shareholders and partners. With a growing pipeline, a strong network of collaborators and platforms built for efficiency and scalability, we are well positioned to lead in the global production of enzymes, alternative proteins and biopharmaceuticals, meeting the demand of today and shaping the solutions of tomorrow. I would now like to turn the call over to our Chief Operating Officer, Joe Hazleton, to provide an update on business results for 2024.

Speaker 3

Joe? Thank you, Mark. Twenty twenty four was a transformative year for Dyadic International as we advanced our mission to improve global access to affordable high quality proteins through our C1 and DAPRIS microbeal protein production platforms. While Dyadic remains committed to human and animal health platform and product opportunities for mid to long term growth, today, I want to emphasize our progress and near term revenue potential in the non pharmaceutical and reagent product markets, which continue to show robust momentum and commercial readiness across our three areas of focus in alternative proteins, life science, food nutrition and bio industrials. We're making strong strides for commercializing several cell culture media components, each addressing growing industry demand for animal free, cost effective and high performing alternatives in the life science segment of alternative proteins.

Speaker 3

Recombinant human serum albumin, RHSA being developed through our partnership with ProLiant Health and Biologics is on track for commercial launch in 2025. RHSA is a foundational product for diagnostics, bioproduction and vaccine formulation. Our recombinant transferrin product is also progressing well with active partner engagement and sample distribution underway. In initial cell proliferation studies, Dyadic's recombinant transfer and protein demonstrated comparable performance through a recombinant reference standard, highlighting its potential as a high quality, cost effective, non animal alternative for research and commercial bioprocessing applications and we are currently exploring opportunities for scale up and licensing. Furthermore, Dyadic is advancing the development of recombinant fibro breast growth factor, FGF products for cell culture media and biopharmaceutical applications.

Speaker 3

As a critical driver of cell growth and proliferation, recombinant FGF plays an essential role in biomanufacturing, regenerative medicine and cell based therapies, particularly in serum free and chemically defined cell culture media. Initially, cell proliferation initial cell proliferation studies have demonstrated that Bionic's recombinant FGF products exhibit comparable performance to reference standard recombinant FGF. In addition to further characterization and validation efforts, sampling initiatives are expected to begin in Q2 twenty twenty five. These cell culture media components position Dyadic to capitalize on growing diode production needs with high quality non animal cost advantage solutions. In the alternative protein, food and nutrition space, Dyadic is unlocking new opportunities across non animal dairy, nutritional science and research applications.

Speaker 2

We are

Speaker 3

actively developing high value recombinant whey and other proteins including alpha lactalbumin, caseins and human lactoferrin, all of which are in high demand for use in infant nutrition, functional foods, wellness products and pharmaceutical applications. Sampling and optimization efforts are ongoing with increased interest from potential collaborators across the R and D and non animal dairy sectors. These proteins offer sustainable animal free alternative to traditional dairy based ingredients, addressing a growing consumer and industry shift towards ethically sourced and health promoting proteins. In parallel, our dairy enzyme portfolio is progressing rapidly through our partnership with an EU based commercialization partner. In 2024, we achieved a productivity milestone of $425,000 for one of our recombinant dairy enzymes with a commercial launch anticipated in late twenty twenty five.

Speaker 3

Additional enzymes are in development under our licensing agreement signed in 2023, expanding our reach into dairy processing and functional ingredient applications. Together, these programs provide Dyadic with a strong foothold in the expanding animal free dairy and specialty nutrition markets where the demand for scalable, functional and animal free protein solutions continues to accelerate. Dyadic is also making significant progress in the Life Sciences segment of our alternative proteins business with the development of a suite of DNA and RNA related reagent enzymes, which are a natural and strategic fit for our proprietary platforms. One of the leading candidates in this vertical is our RNase free DNase I enzyme, which is now in the final stages of process validation. We're actively partnering with a European Contract Development and Manufacturing Organization or or CDMO to initiate research grade production.

Speaker 3

This enzyme serves a broad range of applications, including molecular diagnostics, gene therapy and biologics manufacturing where high purity and consistency are essential. In addition to DNase I, Dyadic is expanding its enzyme portfolio with the development of four additional reagents, including RNase inhibitors and T7 RNA polymerase. These are foundational tools in DNA and RNA manipulation, in vitro transcription and next generation sequencing workflows, which are key technologies that support genomic research, therapeutic development and synthetic biology. Early development and optimization efforts are progressing with initial data and validation results expected by the end of twenty twenty five. This reagent enzyme market offers Dyadic a scalable recurring revenue opportunity with relatively low regulatory hurdles and a shorter path to market compared to traditional biopharmaceutical products, enabling faster commercialization and greater near term impact across our life sciences sector.

Speaker 3

Dyadic is also advancing its presence in the bio industrial sector of our alternative protein segment, where our DAPA BIST protein production platform is being leveraged to support sustainable large scale enzyme solutions across multiple industries. In 2023, we entered into a development and commercialization agreement with FarmboxBio, a synthetic biology research and manufacturing company. This collaboration led to a significant milestone in May of twenty twenty four with the launch of n3zym, an enzyme cocktail produced using dyadic staphylaxis platform. N3zym is specifically designed to enhance the efficiency and cost effectiveness of converting pretreated agricultural residues into fermentable cellulosic sugars, which is a key part of the critical process in the production of renewable chemicals, biofuels and other bio based products. Beyond this partnership, Dyadic has continued to develop a broader portfolio of enzymes with potential applications across a wide range of bio industrial markets, including nutrition, biogas production, biofuels and biorefining.

Speaker 3

These enzymes are currently being sampled and evaluated by interested commercial partners as we work to identify optimal fits for industry specific use cases. This segment represents a promising area of growth where we believe our platforms can contribute to reducing reliance on fossil fuels and improving the economics of sustainable industrial processing. While the alternative protein segment drives near term focus in revenue, our longer term value in human and animal health is supported by our ability to partner with leading global institutions. As part of our ongoing strategy to expand the reach and impact of the added platforms, we continue to strengthen our position through strategic grants and non dilutive funding partnerships that support long term innovation. Last week, we announced a significant milestone with the receipt of a $4,500,000 grant from the Coalition for Epidemic Preparedness Innovations or CEPI awarded to Foundation Biotechnipolo de Siena or FBS to accelerate the development and manufacturing of recombinant protein vaccines using Dyadic C1 platform.

Speaker 3

With the project already underway, this funding will support key steps including antigen design, cell line development, process optimization, product characterization and scale up to cGMP manufacturing. As a subcontractor on this initiative, Vionic is expected to receive $2,400,000 of the total grant amount. In November of twenty twenty four, Vionic was awarded a $3,000,000 grant from the Gates Foundation to support cell line development for monoclonal antibodies targeting Respiratory Synchillovirus or RSV and malaria. These programs powered by our C1 protein production platform are focused on delivering affordable, scalable solutions for treating infectious diseases in underserved populations, further aligning our work with global health priorities. In collaboration with FBS and other partners, Dyadic has also submitted multiple new grant applications aimed at expanding the development and adoption of the C1 platform across additional vaccine and antibody programs.

Speaker 3

As a very recent example, on March 23, CEPI announced the award of a $2,600,000 grant to UVAXBIO. This funding will support the development of Ameris vaccine and research to assess the capability of the C1 platform to speed vaccine production and lower manufacturing costs, improving access to vaccine doses in the future. These ongoing efforts not only bring in meaningful financial resources to advance research and development, but also enhance our global visibility and validate the competitive advantages of our platform in addressing urgent health challenges worldwide. Dyadic continues to advance its pipeline of innovations in both animal and human health, demonstrating versatility and rapid development capabilities of C1. In collaboration with Zirovax, we're developing C1 produced self assembling ferritin nanoparticle antigen targeting H5Ab influenza or bird flu for potential use of diagnostics and vaccines across poultry, cattle, humans and companion animals.

Speaker 3

With the ongoing bird flu outbreak posing significant risks to both agriculture and public health, we are actively conducting pre commercial research and validation to support potential strategic partnerships and licensing opportunities. Additionally, our mpox vaccine or monkeypox vaccine candidate also developed a partnership with Verevax is an early stage preclinical development. This project not only expands our infectious disease portfolio, but also provides further validation of the C1 platform's ability to rapidly produce cost effective non mRNA vaccine candidates. In diagnostics and vaccines research, our C1 produced adjuvanted ferritin nanoparticle H5.2.3.4.4b Astracon vaccine has shown cross protection against multiple H5 virus strains in early studies. In poultry, early trials demonstrate the generation of neutralizing antibodies supporting the potential for commercial viability in both vaccine and diagnostic applications.

Speaker 3

In cattle, preliminary diagnostic and vaccine data have shown similar cross protective potential, opening the door to a broader adjustable market in the Livestock Health segment. We're also we have also expanded our collaboration with Thibro Animal Health or ABIC Biological Laboratories to develop vaccines for diseases affecting livestock animals. This partnership strengthens our strategic position on animal health and further supports the application of C1 as a cost effective and scalable solution. Beyond these programs, Dyadic has also successfully expressed a high yield, high purity RSV F trimer antigen along with several other antigens of monoclonal antibodies. These developments further validate the flexibility and efficiency of the C1 platform in addressing a wide range of human and animal health challenges, while continuing to support our longer term biopharmaceutical pipeline.

Speaker 3

With that, I will turn the call over to our CFO, Ping Rasun to cover our financials. Ping?

Speaker 1

Thank you, Joe. Thank you, everyone for joining our call today. I will now go over our key financial results for the year ended 12/31/2024 in more detail. You can find additional information in our earnings press release and Form 10 K, which we filed earlier today. As of 12/31/2024, we have cash, cash equivalents and investment grade securities of approximately $9,300,000 compared to $7,300,000 as of 12/31/2023.

Speaker 1

Revenue for the year ended 12/31/2024 increased to approximately $3,495,000 compared to $2,899,000 for the year before. The increase is driven by the license revenue of $1,000,000 from per line and approximately $890,000 from enzymes, including success fees in 2024. Cost of research and development revenue for the year ended 12/31/2024 decreased to approximately $1,195,000 compared to $1,976,000 for the year before. The decrease in costs of revenue was due to higher individual contract amounts on certain research funding and related work performed during 2023. R and D expenses for the year ended 12/31/2024 decreased to approximately $2,044,000 compared to $3,297,000 for the year before.

Speaker 1

The decrease was due to the completion of the company's Phase one clinical trial of DYA-one hundred COVID-nineteen vaccine candidates. G and A expenses for the year ended 12/31/2024 increased to approximately $6,135,000 compared to $5,817,000 for the year before. The increase reflected increases in business developments and investor relations expenses of approximately $294,000 share based compensation expenses of $109,000 professional service expenses of $82,000 and other increases, partially offset by decreases in management incentive expenses of $124,000 legal expenses and insurance expenses. Loss from operations for the year ended 12/31/2024 was approximately $5,901,000 comparing to $8,230,000 for the year before. Net loss for the year ended 12/31/2024 was approximately $5,809,000 or $0.2 per share compared to a net loss of $6,795,000 or $0.24 per share for the year before.

Speaker 1

As previously disclosed, the company was awarded a 3,000,000 grants from the Gates Foundation in November 2024. Additionally, in March 2025, our partners received two awards from CEPI to support C1 antigen development and accelerate advancements of the C1 platform from which we expected to receive additional fundings. These initiatives are expected to create additional revenue growth opportunity in 2025. Now, I will ask the operator to begin our Q and A session, after which Mark Immelphard will provide closing remarks. Operator?

Operator

Thank you. We will now be conducting a question and answer session. Okay. Looks like our first question comes from John Vandermosten with Zacks Small Capital Research. Please proceed with your question.

Speaker 4

Great. Thank you. And how are you doing, Mark, Ping and Joe?

Speaker 2

I thought I'd

Speaker 4

start out with a question on the Gates Foundation and CEPI grants. It seems like there's a lot of interest in them in you. And I heard you mentioned that there are some other grant applications that you had made. Maybe you can reconcile, I guess, how the Gates Foundation fits in and if some of those grants are in that area and also their interest in C1 because it seems like they've done a number of things that recognize its value.

Speaker 2

Thanks, John. To address your first question, yes, we have a number of additional grants we've applied and our collaborators have applied for C1s embedded in those programs. And that's both Fort Gates and CEPI as well as other non profit organizations, government grants in different countries. So of course, you can tell by Gates giving us a $3,000,000 grant, they have a significant interest. We've been having calls with them already.

Speaker 2

I think they're excited about how fast it has seen in the work we're doing compared to the two cells that traditionally used to seeing with the monoclonal antibodies. In fact, they mentioned how surprised they were, how fast we were already getting transformers. And CEPI, we're just getting started. But I think the key here that I think you pointed out is these are two of the largest nonprofit funding organizations on the planet related to vaccines and antibodies and global health. So I think that the money that we're getting directly and through these foundation biotechnology, the Ciena, the grant announced yesterday by CEPI with UBED Bio, these are driving forward the innovation and the advancement of our platform not only to make it quicker, faster, better and cheaper, but quite frankly, it's already produced its kinks at remarkable levels fast and quick.

Speaker 2

But it's bringing adoption and use to to potential products that are going to be put into human beings at some point down the road as we hope to turn into life saving medicines that we can make profits on from our shareholders and bring global health to the humanity. And then on the animal health side, fibro, as Joe mentioned, is advancing towards commercialization on one or two of the animal health vaccines. And as you know, with the USDA just announced recently $1,000,000,000 in funding for potential human health or animal health and $100,000,000 of that is partly going to be assigned potentially for vaccines and we actually got notice yesterday from them of a potential opportunity to apply for that grant, which we intend on evaluating and potentially doing on our own and or in collaboration with academics and industry and non profit organizations. So hopefully that gives you a flavor for the fact that quite frankly, we're seeing more interest in our platforms, our technology and the products we're producing than we've ever seen.

Speaker 4

Okay. And we're also excited about the album in sales. And Joe, I think last time we spoke a couple of months ago, you were walking through some of the steps that you needed to complete before getting that first product revenue dollar through the door. Can we revisit kind of how you've come along since then? And it seems like maybe in the next weeks or month or so, yes, that milestone may happen of getting that dollar through the door.

Speaker 4

Can you update us?

Speaker 3

Yes, absolutely, John. And then first of all, thanks again for the questions. Always appreciate your perspective on these things. And when you look at the albumin market, obviously, we're excited to enter into commercialization. I think the key for us is continuing to rapidly accelerate scale up and we're doing that in conjunction with Proline Health and Biologics.

Speaker 3

We have made progress and obviously we have to do it right. We have to make sure the product is validated, QC testing is done and it's produced according to the right specifications in order to have a successful launch. In addition, starting to sample, that's going to be the first key, which we do hope and it will be happening very soon. But again, we remain committed to pushing and hopefully commercializing in early twenty twenty five. So we're still pushing.

Speaker 3

It's still about scale up and making sure the product is qualified and that just takes time. There's really no shortcuts you can take. It's kind of like, I don't want to say developing a drug, but in some instances you do have to make sure you meet the right product specifications, especially if you want your customers to be switching to a recombinant product versus, let's say, an animal derived. So you want to make sure everything is basically all set and all systems point to go before you put a product on the market and then realize something is wrong. So we're just making extra sure and doing all the qualifications in QC to make sure these products are high quality, high purity and that they'll meet our customers' needs.

Speaker 3

And again, hopefully, we still continue to push and have that commercialized as quickly as possible.

Speaker 4

Okay, great. Thanks, Tim. I'll hop back in line. Thank

Speaker 2

you. I think you're going to the next all right, go ahead.

Operator

I'll just say our next question does come from Bernadino with H. C. Wainwright. Please proceed with your question.

Speaker 5

Hi, everyone. Thanks for taking my question and congratulations on a great quarter and getting this SUFI grant. I was just wondering if you can help us a little bit with determining the cost of research and development revenue. Just wondering if you could talk a little bit about the components that help us how to figure that out?

Speaker 2

Well, I think the important part is 80% of the research and development expenses are covered by somebody else with some profit margins built in for us. So the CEPI grant for the 4,500,000 of which we're going to get to point four directly, but the $4,500,000 is all going towards the developing C1 as Joe pointed out towards Phase one launching capabilities and increasing the speed to keep up with mRNA proteins and vaccines. And we believe actually that we can do that and we've demonstrated that we can create stable cell lines already within twenty one days. So that's very fast and they're very productive and they're mass producible at very low cost without the need for extreme cold chain storage. But I think the point here is all that money is advancing this platform and innovation and driving it to the point where adoption and use in big pharma, government agencies, academia, it all starts by putting the gene into a cell line and like UVAX Bio in the CEPI grant that was announced yesterday, we're getting $2,600,000 from CEPI to advance their MERS program.

Speaker 2

We're going to produce the antigen that goes in there that's going to be ultimately a vaccine, the active component of the vaccine. So the more of these opportunities we get, the more demonstration of safety, efficacy, speed, yield, cost, the momentum is building and it's accelerating. And as we mentioned in the past, Reno Recchioli is one of the godfathers of the vaccine space. He's the head of the Foundation of Biotechnology, Ciena. That took us longer than we expected to get embedded there, but he's been out promoting our technology for over a year and a half to a variety of different government organizations, pharmaceutical companies, academia, etcetera.

Speaker 2

And we expect more things to come from that collaboration in the not too distant future.

Speaker 5

Great. And follow-up on the CEPI grant. The grant is to FBS, right? The press release said that the T1 produced protein engines can be compared traditional mammalian approaches. Just wondering, what is FBS' experience see, results from their work?

Speaker 2

Well, FBS' experience is probably thirty years with Reno Rapioli as a former GSK, Chief Scientific Officer at Novartis before that, at Chiron before that. As I mentioned, he's like one of the godfathers of vaccinology. He's probably taken 10 or 12 drugs through the clinic into commercialization over time. So the good news is that we've seen already in another funded program where we've actually worked with UC Davis and we're working on that publication that the C1 produced full spike protein actually performed virtually identical to the hexyl protein. So we're expecting very good results from that program very soon.

Speaker 5

So will the comparison be in vitro or

Speaker 2

some kind of yield number? No, it would be in animal models, which is what we've already done. So you'll see when the publication comes up and we can virtually make same thing, same quality, same efficacy, just faster, quicker and cheaper without the need to do viral clearance. So in the downstream, we can speed it up with less cost. On the upstream, we can blow it away in terms of speeding costs.

Speaker 2

And we've already seen at least in the mice trial that have been compared head to head at least with a microneedle approach that we were equal to the hex cell, which is actually human cell, which is actually better than the Chocell.

Speaker 5

Great. Next we're taking my question and congrats again. I'll get back in the queue.

Operator

Thank you. And our next question comes in from John Vander Mostyn with Zacks Small Capital Research. Please proceed with your question.

Speaker 4

Great. Thank you. So you had mentioned that by year end that you may begin commercialization of the dairy enzyme. Can you also walk me through the steps there kind of like you did with the with the albumin? What needs to get done before again that first dollar can flow through the door?

Speaker 3

Sure, John. It's Joe. And again, thanks. This is similar, I guess, a little bit to research grade in terms of it does require some level of regulatory oversight in cases of food, proteins or enzymes depending on the market you're launching into for Europe, it's part of the EMA that deals with food type or food proteins in The U. S.

Speaker 3

It's grass. So essentially the product has been filed for sulfur front grass application that should hopefully be I think it is submitted and once that is clear, then they just do the final testing and production and then they're able to put it on the market. So it did similar in terms of the steps, obviously, you need to scale up, prove the quality. In some cases, like in The EU, you do need to do animal testing of food proteins or food enzymes versus The U. S.

Speaker 3

Where it's a little less stringent in some cases. But overall, it's a slightly different, less intrusive regulatory pathway, so they're a little quicker, but you still do have to make sure that you follow the process for development and scale up and then ensure the quality of the product and that it is food grade moving out the door. So right now, as it's scaling up in a food grade production facility, they're parallel tracking the grass application. So that's essentially the main process.

Speaker 4

Okay. And one other question for you on productivity. Do you have the numbers in terms of grams per liter per day for the various applications that you have, the humananimal albumin, the transfer in, and the growth factors, kind of what's the relative, efficiency of those in terms of grams per liter per day or whatever time period that you're using?

Speaker 2

Joe, I think that some of that's proprietary information. So just leave it to be obviously it's high enough that we're getting commercial traction. And I'm glad you brought up transferring and growth vectors DNase one, alpha lactalbumin, because Joe maybe you can expand on all the excitement and interest and progress we've made on all of products maybe one by one.

Speaker 3

Yes. I think the key, John, as you look at it in terms of productivity is that we are able to basically make better margins than traditional recombinant products in the market today due to our productivity. And Marc's right, we can't get into the specifics. But suffice to say that the interest that we're receiving in our non pharmaceutical applications, as Mark mentioned, whether it's transferring in cell culture media is due to the high productivity. These enzymes and cell culture, these proteins and cell culture media like albumin, like transferrin, they are thousands of dollars per gram or even in some cases per microgram.

Speaker 3

So it's very important that we're able to use the productivity of the system to help not only bring the cost down, enables commercialization like cell culture media can be used in pharmaceutical development and manufactured at cGMP levels, but it's way too expensive for markets like cultured meat. And the nice thing about the cell culture media market that we're entering into is it does serve two different areas of the business, whether it be production of lab grown meat or growing CHO cells to manufacture biologics. So that essentially we're able to use these portfolios in cell culture media in two different directions, basically expanding and in some cases doubling and tripling our potential profit margins in these markets. And we're making great progress in the testing, as Mark had mentioned, with the transferring of growth factors, being able to demonstrate that we can grow animal cells just like the products they're using today, except at much higher yields and potentially much lower prices is very interesting. And that's what's driving really the unprecedented interest that we're getting in the platform right now, not just in the alternative protein space, but also in the pharmaceutical space.

Speaker 3

So I think, again, we can't get into the specifics, but if you look across these products, they're all moving forward as quickly as possible and that is going to be our focus is commercialization of products either ourselves or through partners. As Mark mentioned DNase I, we're getting ready to partner with our partnering with the CDMO to scale up a research grade production of DNase I that we can begin to commercialize ourselves or sell in bulk to others to sell. So I think we're positioned correctly in the right high value segments. It's just obviously making sure that we continue to develop these products as quickly and efficiently as possible.

Speaker 4

Okay, great. Thank you.

Operator

Thank you. And our next question comes from Dick Williams with Williams Resource Group. Please proceed with your question.

Speaker 6

Hi, gents. I wanted to touch on a couple of things. Having been a shareholder for a great number of years and gone through the projects that didn't really materialize, It seems that Zappy, it was one for five years. We were picked as the best technology for the future. It seems it was unanimous and of course that the whole group including AstraZeneca has really not done anything.

Speaker 6

But it appears that the CIPI is something that will happen. The one other factor with the CIPI release was they also had put out a release that I got buried in their material with UFAX where they mentioned that they had given them the $2,600,000 but also in the vaccine development, whatever it is for, that they would be using the C1 manufacturing system for whatever it was, which obviously gave us some good accolades. It didn't get much attention, but it was buried, but that was significant. Now we finally have an opportunity with an organization that appears to be making product that will be sold and we'll start to get revenue because I think Joe, in terms of your area, it's so significant. If we were to dissect it down to try to see where the revenue stream opportunity comes from, from these various products and the margins, I mean, we we'd probably be on the phone for four hours, but can you give us an idea as to the market size opportunity in some of the segments in your area that you mentioned as well as ProLiant?

Speaker 6

I've checked out ProLiant, it's a very large corporation. This isn't an mom and pop guys. They have a full worldwide sales force, several manufacturing facilities and they're going to launch a product that we will get revenue from in a matter of months, I presume. We don't have a date, but I believe it's somewhat in a matter of months. And this is serious revenue that could flow to us and probably the most immediate revenue for us of technical aspects.

Speaker 6

I like to hear about the money aspects, profit motives and revenue streams that can come in from all of these projects. And this will be the refreshing part of the new Dyadic. For five years, all we've heard was research projects with no revenue. We finally have arrived at the point where now we can produce revenue for all of the stakeholders as well as with the peak one Wall Street to give the recognition we so truly

Speaker 2

deserve. Before Joe, can you

Speaker 6

kind of dissect that? And then the other thing, excuse me, is another factor that has kind of gone, I think, fallen by the Board because we're doing so many things and we see that market opportunities for them. But I was around five, six years ago when this company did upwards of close to $100,000,000 over, I forget what period of time in the bio industrial sector. Real revenue produced by Mark before Joe joined with this new area. And that area I understand is blossoming again.

Speaker 6

And one of the opportunities for us to go back into and offer the products we now have for that industry. So can you give some color on where we are and what type of an effort, Mark, you're going to put forth to go back to your old people and get some serious revenue from them?

Speaker 2

Yes. Well, let me answer the first question. For the last

Speaker 6

I know it's a mouthful, but you

Speaker 2

Right. Look, Dick, we're going to run out of time here. So I love you guys. We appreciate your thoughts. You're a great supporter.

Speaker 2

We love all our shareholders and partners and employees, but we didn't just twiddle our thoughts the last five years. We developed platforms first from pharmaceutical to revolutionize and transform speed, cost and yield and release. And you have to have a platform before you can make a product. If you can't make a product in an inefficient platform or you're going to fall short or it's going to be people are going to die or suffer, which is what's happening in the world. And we took the time and effort to do it right.

Speaker 2

And we got a ton of funding from pharmaceutical companies. We spent some of our own money on it. We got funding from governmental agencies. You had the Israeli government, you had the EU ZAPI program. You had all kinds of things coming in that advanced it to make and wake up The Gates Foundation said, didn't just wake up yesterday.

Speaker 2

We've been talking to these people for years. It got to the point that they recognize that we actually have the keys to the kingdom to really improve speed, yield, cost and release of not just pandemic, we're talking about traditional oncology drugs, arthritis, dementia, Alzheimer's, you name it, we can probably make it in a more efficient way at lower cost faster. And once we get these things into the clinic and through the clinic, the doors are going to open up. So if you don't have a platform, you can't do any of this. So we haven't just been twiddling ourselves for five years and these guys didn't just show up.

Speaker 2

They showed up because we actually did what we said we were going to do and we did it for a fraction of the cost than most other people would have done. On the industrial side or the alternative protein and Joe is going to answer all those questions, we started with DAPA plus to do the same thing at an accelerated pace, taking the learnings and education that we have and our CDMOs and research partners have. And we brought this out very rapidly, very quickly to do as you point out to go after an industry that's even more valuable than what we did before when we generated $30 plus million in non, let's say, a dilutive funding from Shell, Avango, BioS, BASF and then the $75,000,000 from DuPont. But alternative proteins for alpha lactalbumin for transferrin, for FGF, for DNase I, those margins are much higher than what we had in the industrial section, albeit we are going after some of those industrial products and Joe will talk about too. So now I'll let you go.

Speaker 2

But without these platforms, we wouldn't be making anything and our customers will be making anything that would be commercialized. So let's just leave it there and Joe maybe you can jump in.

Speaker 3

Yes. And Vicki, I think you hit the nail on the head there. The markets that we're entering into are by design and they're high value markets where our technology has a significant advantage in terms of its productivity. When you look at the human albumin market, that's roughly a $5,600,000,000 market and I believe it's growing in double digits per year. And that's driven by a lot of the increase in the amount of vaccines being produced, not just in human health, but also in the animal health.

Speaker 3

And as we look to some of the other markets like DNase I and other RNA, DNA and RNA enzymes, that's a DNA or the end of the glaze market, the DNase and ligase market is around $900,000,000 And again, it's growing at almost double digits, I believe a year as well. You look at things like non animal dairy proteins, that's a $26,000,000,000 market. And that's where like alpha lactalbumin, lactoferrin, those things can play. Each of these products also has a distinct, not all of them, but some of them have a distinct market like Aflacodilmium. It doesn't just play in the non animal dairy space.

Speaker 3

It also potentially can play in pharmaceuticals and it plays as a research varied agent for nutritional and biochemical studies. So each one of these products has different markets. But I think the key that I want to emphasize though is, even though we're in all of these markets and we're developing products for high value segments, what we do remains the same. We develop cell lines, but that's what we do. We take a DNA sequence and we put it into our cell line.

Speaker 3

So we are while we're targeting multiple areas, we're targeting the right partners as you mentioned with the Croline Health and Biologics. They're a major player in the albumin space. You look at even UVAXBIO, you look at Cepheid Gates, we're targeting the right partnerships and the right potential partners for these products, because we can't do it as Dyadic. And I think that's the key. What we're doing remains the same and we're staying focused on that.

Speaker 3

And that is creating products in these non pharmaceutical or reagent segments that we can quickly commercialize due to the fact that we have high productivity and obviously potentially lower costs from sectors, what's driving the interest. So you look across, there's not a lack of available market to go after. It's getting the product to the market and identifying the right partner to help us commercialize. And that's really what we're trying to do right now. But I think we're seeing unparalleled interest in all of our segments right now.

Speaker 3

And it's due to the fact that we are starting to move closer to commercialization. And I think as soon as we get the first product on the market, that's going to be another driver for us or another inflection point that we can use to continue to expand the adoption. So I think hopefully it gives you a flavor for the size of the markets that we're going into and the capability that are potentially that these products can have.

Operator

Thank you. And our next question comes from Tony Bowers with IntraAct. Please proceed with your question.

Speaker 6

Hi, I applaud Mark for his patience and persistence on the human side. But thankfully we've got what Joe has been working on, particularly in this environment. Given the sort of international turbulence, the turbulence in Washington, is there anything that is kind of obstructive other than the uncertainty of grants to your business plan? And then a separate question is, where do we stand with all of the great work that was done in South Africa and the provenance that you've developed there?

Speaker 2

How

Speaker 6

long will it be before we see all sorts of biologics with Dyadic inside the way we've seen Intel inside computers?

Speaker 2

Tony, good questions. First and foremost, we are completely focused on the non pharmaceutical side of the business to drive revenues. We're developing multiple products there. But at the same point, we're not going to turn down $7,500,000 for the financing non dilutive funding that we have some profit in to advance the platform. And the learnings that we get from the pharmaceutical side of the development, we can apply also and are applying on the other side, okay.

Speaker 2

But our focus is currently driven by albumin, transferrin, DNase I, alpha lactalbumin. We're developing some cellulosic enzymes for biogas, biorefining, cellulosic sugars. So Joe can jump into all that, but I want you to know that. Yes, we realized that the environment has changed, but long before the environment changed, we started targeting these other areas as bringing in revenue and profit sooner. So, Joe, you want to go into that?

Speaker 3

I mean, I think, you've probably put it well. I think the key, Tony, you've mentioned what we're doing with Rubicon South African, where that stands. But right now, they've shifted their focus to animal health and animal health vaccines. And right now, they're developing, I believe, up to five animal health vaccines because they're a little obviously commercialized in human vaccines at this point. The Phase one study that we completed with Rubik for DUA-one hundred was a milestone event for Dyadic.

Speaker 3

And I think it's what's helping drive this increased interest from people like Gates and CEPI and the fact that we have been in humans with a protein producing system. Unfortunately, we were a little bit late to the party in the COVID space and And I think we'll continue to evaluate that with Rubik, but right now their focus has shifted towards animal health. And I know that they're looking to hopefully have something have some clinical studies at I think the tail end of this year. So I think there's definitely opportunity there. It's just we're probably going to do it in animal health before human health in that market.

Speaker 6

It's been expected that will the animal health products have to be funded by a government program?

Speaker 3

I don't know if you necessarily need to be funded by government program, but they could be. I think they're also looking at other sources of funding and revenue as well. So I don't know, Mark, if you have any greater insight there.

Speaker 2

Yes. Actually, I'm heading there next month. So I'm going to go down to Johannesburg and I'm going to have a meeting with them for two days. I do have a little more insight than Joe does because I'm going there. And they already have, I think they're working on a challenge study already, it's already funded for animal health vaccine.

Speaker 2

And they also have, from what I understand, they have either have received a grant or will be receiving a grant for $1,800,000 for equipment and things like that, working towards getting ready to try to build a facility down there. And I do believe that there are also, as you pointed, raising capital not from government grants, but from equity to bring in several million dollars to accelerate those efforts. I'll have a lot more clarity when I get down there, but I've been in touch with them recently and on a constant basis and they're moving forward. So they're doing very well. They're not going as fast as we'd like, but they also don't have the wherewithal to do the funding that we can get in The United States.

Speaker 2

But the whole issue I want to bring up, and I think it's important because as the elephant in the room, with Trump and Elon Musk are doing in Doge and gutting out all these different programs, guess what, we don't have any of those U. S. Government programs, so we're not getting gutted. But the thing is, there's a shift and the shift is going to cost efficiency, lower cost, big government money. In some ways, what's going on in D.

Speaker 2

C, we believe is playing into our hands. It's going to help us accelerate the technology and the platform sooner because if you want to lower your cost of drugs, you better make them cheaper. If you want to make more of them, you better make them cheaper. I want to stretch the dollars you don't have or less dollars to live on, you better make more for less. And that's the message.

Speaker 2

And I think that's the message we've been resonating. That's common sense. So I don't know what's going on in DC, but I think that You better find a more efficient way of And we've had discussions the yesterday at 01:30 with a senior person to the FDA. I have a call with Brad on Friday. He said, there's things going on.

Speaker 2

I don't know if they're going to turn in any money, but they're happening and I think everybody's realizing cost of goods matters because without that, we have an unsustainable model in America, let alone across the globe. So this may actually be working out in Dyadic's favor. And also the whole twist about mRNA vaccines. I'm not saying whether it's safe or not, I'm not going to get into that debate, but this has been created for the mRNA vaccines. So if we take a step back, which is what I think that RFK and Trump are doing on mRNA, it may open up the door for the spotlight to be focused on the more durable, faster, lower Thanks.

Speaker 2

I think, yes,

Speaker 6

I think it's a we've got a really good outlook here. So keep up the good work.

Operator

Okay. And our final question comes from Stephen Raphael, private investor. Please proceed with your question. Okay. And with that, it doesn't look like there are any more questions.

Operator

I'd like to pass the call back to Mark Emelfarb for closing remarks.

Speaker 2

Well, I almost feel like we're already done, but I'll close it anyway. Okay. Looking ahead to 2025 and beyond, our strategic priorities are clear and focused. We're launching our first commercial products. We're expanding strategic partnerships and alternative proteins and industrial bio materials.

Speaker 2

We're broadening the adoption of our microbial platforms across numerous markets. We're preparing to launch our first commercial product in recombinant albumin, non animal dairy, DNase one, cellulosic enzymes making a major milestone in dyadic's evolution from biomanufacturing platform development to revenue generation. At the same time, we plan to expand strategic partnerships across key sectors including the alternative protein segment, diagnostics, research tools, leveraging the growing interest in sustainable animal free and high performance protein solutions. We will also continue to leverage our proprietary C1 and DAPA plus platforms to meet the rising global demand for affordable and efficient biomanufacturing technologies across all the markets. With a strong IP portfolio and an expanding product pipeline and increasing global recognition, Dyadic is well positioned to be a disruptor in the biomanufacturing space and a revenue generating engine delivering tangible near term value for shareholders.

Speaker 2

Our C1 and DAPA business platforms are engineered to maximize efficiency, ensuring that funding goes further to meet the needs for more efficient high yield protein production in today's rapidly evolving landscape. We're excited about the opportunities that lie ahead and remain committed to driving innovation, accessibility and growth across all areas of our business. Thank you for joining today's call and a special thank you to our investors, partners, employees and board members who have made 2024 a standout year. We look forward to delivering continued growth and innovation in 2025 and beyond.

Operator

Thank you. And with that, this conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

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Earnings Conference Call
Dyadic International Q4 2024
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